36C25919Q0324-001.doc

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID:

1. Contracting Activity:

Organizational Activity:

Department of Veterans Affairs, NCO 19

George E. Whalen VA Medical Center 6162 s. Willow Drive, Suite 300

500 Foothill Drive Greenwood Village, CO 80111

Salt Lake City, UT 84148

2. Nature and/or Description of the Action Being Processed:

The Government intends to award a firm fixed price contract for the acquisition of Arrow® AC3 Optimus Intra-Aortic Balloon Pump Consoles (“Arrow® AC3 Optimus™”) manufactured by Arrow International, Inc d.b.a Teleflex (“Teleflex”) for the George E. Whalen VA Medical Center, Cardiology Department, Building 1, 2nd and 4th floor, 500 Foothill Drive, SLC, UT 84148 (“Cardiology”). Arrow® AC3 Optimus™ is required to replace the non-functioning, or beyond/nearing life-cycle Cardiology instruments. Consequently, some lost the ability to read the fiber optic sensor; the intermittent lack of this capability could interfere with the provision of proper patient care and prove critical in some cases.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Intra-Aortic Balloon Pump (IABP) is a mechanical device that increases myocardial oxygen perfusion and indirectly increases cardiac output through afterload reduction. It consists of a: a) cylindrical polyurethane balloon that sits in the aorta, approximately 2 centimeters (0.79 in) from the left subclavian artery, and b) computer-controlled mechanism (pump). The balloon actively deflates in the systolic deflation and inflates in the diastolic inflation. These actions combine to restore balance between supply and demand for oxygen needed for the heart and other organs to function properly. The instruments are used in the following situations: a) cardiogenic shock, b) reversible mechanical heart defects, c) agina, d) cardiographic surgery, e) preoperative use in high risk patients, f) non-surgical procedures used to treat heart stenosis of coronary arteries, g) high risk coronary artery bypass graft surgery, and h) breaking down of blood clots formed in blood vessels.

4. Statutory Authority Permitting Other than Full and Open Competition:

(X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4

( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

FAR13.5 Simplified Procedure for Certain Commercial Items: The authority for applying Simplified Procedure for Commercial Items of FAR 13.5 is 41.U.S.C. 1901 and is implemented by FAR13.106-1(b)(2) for restricting competition on this procurement.

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Arrow® AC3 Optimus™ is the newest solution on the market; only available from Telefex. Due to the proprietary nature of the real-time WAVE® Algorithm, no other vendor but Teleflex can provide the required IABP. The main feature of this product is the ProActive CounterPulsation system enabling 98% inflation timing accuracy during IABP therapy, even when patients have severe arrhythmias. This provides the unique ability of the AutoCAT2 WAVE® system with FiberOptix® catheter technology to proactively anticipate individual arterial pressure closures before they occur, and provide accurate inflation timing, as well as triggering even during severe arrhythmias. The FiberOptix® catheter captures and transmits the high-fidelity arterial pressure signal at the speed of light, overcoming the delays seen with traditional fluid-filled arterial pressure (AP) signal systems. Teleflex proprietary real-time WAVE® Algorithm is the brain of the pump-it calculates aortic flow based on the AP signal for each beat (using real-time data). This enables it to capture every single heart beat and then signal the pump to inflate. In heart failure cases, precisely timed IABP is critical for generating beat-to-beat improvements in systolic and diastolic left ventricular performance. No failure of Teleflex balloon have been reported, over its lifetime. This is important because a mechanical failure of the balloon requires immediate removal, which can lead to serious complications caused by micro clots that form on the balloon surface, e.g.: a) peripheral thrombosis, b) myocardial ischemia, c) hemodynamic decompensation, and d) late pseudoaneurysm.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

The Government considered the possibility of entering into a supply relationship with Marquet (Getinge Group) (“Marquet”), which is the only close Teleflex competitor in the IABP market. However, market research revealed that Marquet offers traditional fluid-filled IABP instruments, only. The use of fluid-filled instruments on patients with arrhythmic episodes can lead to poor patient support. Further, Marquet IABPs use predictive timing technology to capture heart beats, which is not capable of capturing every heart beat. Teleflex replaced this technology with the real-time WAVE® Algorithm, referred to in part 5 above, fifteen (15) years ago. In 2018 FDA reported a recall of Marquet CS100i, CS100, and CS300 intra-aortic balloon pumps manufactured July 1, 2003 to June 16, 2017 related to false blood detection alarm and igress of fluid into the intra-aortic balloon pump. No recalls were reported on Teleflex IABPs. When it is time to replace the current IABP instruments, all effort will be made to solicit a comparable products on a competitive basis.

7. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market Research was conducted by searching VA’s NAC website, FPDS and GSA Advantage, and conducting pre-solicitation exchanges with Industry. The results indicated that Arrow® AC3 Optimus™ package is available from Marathon Medical Corporation (“Marathon Medical”), a service disabled veteran owned business (SDVOSB) and directly from Arrow International, Inc d.b.a Teleflex (“Teleflex”), a large company. Additionally, FPDS search shawed that various NCOs purchased in 2018 Teleflex IABPs on a competitive basis from Marathon Medical, at a price lower than that of similar IABPs purchased from Marquet (at the same time). Similar products were also purchased directly from Arrow International Incorporation in 2007. Teleflex provided the Government with a letter dated February 8, 2019, stating that Marathon Medical is, at this time, the only authorized Service Disabled Veteran Owned Small Business (SDVOSB) distributor of the following Arrow International products: AP-0700, IAA-01004, IAA-00175, IAT-CE32, IAT-CE33 (“Arrow® Intra-Aortic Balloon Pump System”). The letter also confirms that the U.S. Department of Veterans Affairs (VA) will be the beneficiary of the manufacturer's warranty provided directly by Arrow International, Inc with respect to the above-mentioned products, if purchased through Marathon Medical. The Contracting Officer has a reasonable expectation that this product is available to the VA from an authorized SDVOSB distributor of Teleflex and, directly, from a large manufacturer, Teleflex.

8. Any Other Facts Supporting the Use of Other than Full and Open Competition:

There are no other facts or circumstances supporting the use of other than full and open competition.

9. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

NCO19 acknowledges the importance of protecting the integrity of the procurement system and arecommitted to working in manner that promotes competition to the greatest extent practicable in order to compete requirements and overcome barriers to competition in future acquisitions. The VA has and will continue to meet with industry on a periodic basis for continued input and feedback on acquisition strategies. Cardiology will continue working with the NCO19 in conducting market research to identify opportunities to compete future requirements.

OFOC SOP Revision 08

Original Date: 03/22/11

Revision 08 Date: 04/18/2018